This differed from Provexis’ submitted claim that stated: “Helps to maintain a healthy blood flow and benefits circulation”.
EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) said this did not reflect the evidence, “because only measures of platelet aggregation have been used in the studies presented whereas ‘blood flow’, and particularly ‘circulation’, depend on many other factors that have not been addressed in the studies provided.”
Provexis, a UK functional ingredients and technology licensing specialist, submitted its water-soluble tomato concentrate for consideration under the emerging and proprietary science article 13.5 list.
The ingredient contains 37 constituent parts and comes in two forms – a water soluble lycopene syrup called WSTC I and a low-sugar powdered derivative, WSTC II.
In backing the claim for adults between 35 and 70 years of age, NDA stated: “In order to achieve the claimed effect, 3g WSTC I or 150 mg WSTC II in up to 250 mL of either fruit juices, flavoured drinks or yogurt drinks (unless heavily pasteurised) should be consumed daily.”
Provexis submitted eight human studies (seven proprietary) and seven (three proprietary) non-human studies in its dossier.
In the seven human intervention proprietary studies, the effects of WSTC on platelet aggregation ex vivo was investigated in male and female subjects between 35 and 70 years of age.
“The Panel considers that both the selection of subjects and the method used to assess platelet aggregation were appropriate for such studies,” the NDA said.
These studies demonstrated reduced blood platelet aggregation after as little as three hours of consuming WSTC-containing products, typically fruit juice drinks. One double-blind, parallel, randomised clinical trial showed a 26.5 per cent decrease in platelet aggregation following consumption of 250mL of filtered tomato juice.
“These human studies consistently show a reduction in platelet aggregation following consumption of WSTC under the conditions of use proposed by the applicant,” NDA said.
“Possible confounding factors likely to interfere with platelet aggregation were adequately addressed. Prothrombin and thrombin clotting times were not affected by supplementation with WSTC.”
It concluded: “The Panel notes a consistent effect of the supplementation with WSTC on platelet aggregation which is sustained for up to 28 days in subjects that are representative of the target population for which the claim is intended. The Panel concludes that a cause and effect relationship has been established between the consumption of water-soluble tomato concentrate (i.e., WSTC I and II corresponding to the specifications provided by the applicant) and the reduction in platelet aggregation in humans.”
The NDA opinion can be found here.